Quality Assurance Functional Lead

WuXi XDC; Singapore; On-site; SGD 120,000 - 180,000; Full time

Job summary

WuXi XDC in Singapore seeks an experienced quality professional to manage issue tracking and client communications during GMP manufacturing. You will coordinate cross-functional teams to ensure timely and effective resolution and complete issue closure.

The role entails acting as the main client contact for quality systems, supporting client audits, managing regulatory documentation, and driving process improvements based on feedback and regulatory updates.

Qualifications

• Bachelor’s degree or higher in a scientific field.
• 8+ years of quality management experience in aseptic pharmaceutical manufacturing or biopharma.
• Strong knowledge of FDA, NMPA, EU GMP, and ICH guidelines.
• Familiarity with sterile manufacturing and quality management systems.
• Excellent communication and cross-functional coordination skills.
• Proficient with standard computer and office software.
• Strong English listening, speaking, reading, and writing skills.

Responsibilities

• Track, document, and close quality issues arising during GMP manufacturing and liaise with clients on status and progress.
• Provide client audit support, including pre-audit information, on-site accompaniment, and Q&A participation.
• Coordinate regulatory and quality documentation for MAH, BLA, and related submissions.
• Bridge clients and internal teams, respond to quality inquiries, and drive continuous improvement from feedback and regulatory updates.
• Oversee deviations, change controls, and CAPA with risk management and timely closure.
• Monitor GMP production batches and ensure delivery of batch records and related quality documentation.

Skills

Quality management

Regulatory knowledge

Cross-functional coordination

Excellent communication

English proficiency

Education

Bachelor’s degree or higher in Chemistry/Biochemistry/Biology/Pharmaceutical Sciences/Biological Engineering

Tools

Office software

Job description

Quality Issue Tracking & Client Communication

• Responsible for the systematic tracking, documentation, and follow-up of all quality issues arising during GMP manufacturing. Serves as the primary interface with clients to communicate issue status and progress, while coordinating internal resources to ensure timely and effective resolution and full issue closure.
• Acts as the main quality contact for clients, responsible for daily communications, relationship management, and quality-related meetings. Accurately understands, interprets, and communicates clients’ quality system requirements and customized needs, and drives internal alignment to meet or exceed client expectations.

Client Audit Support & Coordination

• Supports client on-site audits by providing the audit hosting team with customer background information and project-specific details. Assists in communicating client-specific quality requirements, participates in on-site audit accompaniment and Q&A sessions, and ensures the smooth execution of audit activities.

Regulatory & Documentation Management

• In accordance with regulatory requirements related to MAH (Marketing Authorization Holder), BLA (Biologics License Application), and other applicable regulations, coordinates, compiles, reviews, and ensures the completeness, accuracy, and timely submission of all project-related quality and regulatory documentation packages.

Internal Quality Coordination & Process Optimization

• Serves as a bridge between clients and internal teams, responding promptly to quality-related inquiries from all stakeholders. Coordinates internal resources through cross-functional meetings and participates in or leads continuous improvement of quality processes based on client feedback and regulatory updates.

Project Quality Event Oversight

• Oversees and tracks the execution, progress, and timely closure of project-related deviations, change controls, and corrective and preventive actions (CAPA), ensuring effective risk management for project quality and timelines.

Production Batch Monitoring & Record Delivery

• Tracks the progress of GMP production batches and coordinates internal resources to ensure on-time manufacturing completion. Supports communication and resolution of quality and technical issues arising during production. Upon batch completion, ensures the timely and complete delivery of batch production records and all related quality documentation in compliance with client and regulatory requirements.

Other Duties

• Efficiently completes other tasks and responsibilities as assigned by the supervisor.

Qualifications

• Bachelor’s degree or above in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, Biological Engineering, or a related field.
• A minimum of 8 years of relevant experience in quality management within aseptic pharmaceutical manufacturing and/or the biopharmaceutical industry.
• Strong knowledge of domestic and international quality and regulatory requirements, including but not limited to FDA, NMPA, EU GMP, and ICH guidelines.
• Familiarity with sterile pharmaceutical manufacturing processes and quality management systems.
• Excellent communication and coordination skills, with the ability to work effectively across functions and with external clients.
• Proficient computer and office software skills.
• Strong English language skills, including listening, speaking, reading, and writing.